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FDA 510(k)

SOPHEIA DIGOXIN EIA KIT

K-Number: K832163 · 1983-08-12

ApplicantDiagnostic Products Corp.
Decision Date1983-08-12
Product CodeDPO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SOPHEIA DIGOXIN EIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K832163. The device is classified under product code DPO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPHEIA DIGOXIN EIA KIT?

SOPHEIA DIGOXIN EIA KIT is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K832163.

When did SOPHEIA DIGOXIN EIA KIT receive FDA 510(k) clearance?

SOPHEIA DIGOXIN EIA KIT received FDA 510(k) clearance on 1983-08-12, under 510(k) number K832163.

Who is the listed applicant for SOPHEIA DIGOXIN EIA KIT?

The FDA 510(k) record lists Diagnostic Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOPHEIA DIGOXIN EIA KIT?

The FDA product code for SOPHEIA DIGOXIN EIA KIT is DPO.

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Other records listing Diagnostic Products Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

View all 321 devices →

Related Devices (Code: DPO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K914833IMMULITE DIGOXINCirrus Diagnostics, Inc.K905719ECLIPSE ICA DIGOXINBiotope, Inc.K864449DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KITCanadian Bioclinical, Ltd.K833842RIA COAT DIGOXINImmuno Assay Corp.K830962IMMUCHEM COVALENT-COAT RIA KITImmuchem Corp.K811932COAT-A-COUNT DIGOXIN RIADiagnostic Products Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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